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A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

NCT00481819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-02-24

No results posted yet for this study

Summary

The patients about to undergo kidney transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Conditions

  • Kidney Transplantation

Interventions

DRUG

FK506MR

oral

DRUG

Prograf

oral

DRUG

Mycophenolate Mofetil

oral

DRUG

Methylprednisolone

oral

DRUG

Prednisolone

oral

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Prof. Ao Jianhua · Department of Urologic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00481819 on ClinicalTrials.gov